FDA 510(k) Application Details - K791551

Device Classification Name Hemagglutination Inhibition, Morphine

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510(K) Number K791551
Device Name Hemagglutination Inhibition, Morphine
Applicant TECHNAM, INC.

, US
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Regulation Number 862.3640

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Classification Product Code DLR
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Date Received 08/14/1979
Decision Date 10/17/1979
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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